Fact Sheet
ENVIRONMENTAL
HEALTH & SAFETY
DEA Controlled Substance Program
Overview:
This safety instruction addresses the use of any pharmaceutical grade product in Oregon State University research laboratories,
including drugs classified as “controlled substances” by the US Drug Enforcement Administration (DEA). This is written for Principal
Investigators (PI) or supervisors, as they are ultimately responsible for the use and storage of the substances registered to them.
Oregon State University requires each PI to have an individual DEA registration. DEA Controlled Substances cannot be shared
between PIs, unless both PIs are co-researchers on the same grant and the second PI is listed as an authorized user under the PI
with the registration.
List of DEA Controlled Substances
DEA Controlled Substance Registration Information:
Before registering for a controlled substance contact EH&S for a consultation.
Researchers will use the online Off of Diversion Control Form 225 to register the controlled substance
(https://www.deadiversion.usdoj.gov/webforms/jsp/regapps/common/newAppLogin.jsp). OSU is a Government Funded Research
Facility, and is therefore exempt from registration fees.
The US DEA registration is valid for one year and must therefore be renewed annually. The registered person will be contacted by
the DEA, usually three months prior to its expiration, to renew it. This is usually via email. The DEA will send only one reminder.
DO NOT let the registration expire! If expired, the PI will need to start the process again. The PI or researchers will not be able to
use, buy or dispose of any DEA products without a valid registration and the PI will potentially be in violation of the DEA regulations,
as the lab will be in possession of DEA controlled substance(s) that the PI would not have a valid registration for.
If the PI allows their substance registration to expire and still are in possession of the expired chemicals, contact EH&S to help set a
plan to discard of expired chemicals. NOTE: There are serious consequences for being in possession of controlled substances that
have an expired registration.
Storage Requirements:
All controlled substances must be stored in accordance to the Office of Diversion Control Controlled Substance Security Manual
which can be found at: http://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_non_prac.htm. For any storage questions please
contact Environmental Health and Safety.
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Authorized Staff:
The PI will authorize staff to have access to controlled substance as needed. The PI will need to grant this permission by completing
the Authorized User form. The PI will also need to sign the form. These will need to be kept readily accessible in the lab’s files. The
PI will need a form for each of the authorized lab staff who have access to the controlled substance for three years.
Please note that the PI cannot authorize anyone who is not directly reporting to them to use the DEA products they are registered to
use. Therefore, the PI with the registration cannot allow another PI or their staff to use or buy products under the registration unless
the registered PI is in a direct supervisory role of these individuals or are working as a co-PI on a research project.
Disposal:
The PI will be responsible for disposing of any leftover controlled substance that have expired and will not be used. The PI who owns
the controlled substance may not give them to another PI. If the lab is closing or the PI is retiring, the PI must dispose of those
controlled substances prior to closing the lab or before allowing the DEA registration to expire. Abandoning them for someone else to
deal with is a violation of the DEA regulations and the PI who owns them may be subject to penalties. All controlled substances
that are to be disposed of must have an OSU Hazardous Waste Label that includes the material name, quantity, date, and
license number.
Sharps used for allocating controlled substance must segregated from other waste streams. A control substance contaminated
sharps’ label must contain the material used, date, and licenses number.
For controlled substance and disposal please contact OSU Environmental Health and Safety.
Theft or Loss:
Registrants must notify the appropriate DEA field office and EH&S of theft or significant loss of any controlled substance.
The registrant must then promptly complete and submit the DEA Form 106 regarding such losses or thefts. Thefts must be reported
whether or not the controlled substances are subsequently recovered and/or the responsible parties identified and action taken
against them.
Other Resources:
•
Title 21 Code Federal Regulations, Part 1300-END: http://www.deadiversion.usdoj.gov/21cfr/cfr/
•
Oregon State University Hazardous Waste Disposal: http://oregonstate.edu/ehs/waste
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